Manufacturer registered with FDA

Zhejiang Yahong Medical Apparatus Co., Ltd

Huzhou, China. Lists 7 dental device types with FDA across 1 registered establishment.

FDA owner/operator10045144Foreign exporterManufacturer
Device types listed
7
Brands and models
7
510(k) clearances
0as applicant
Markets registered in
57 registrations outside the US
Establishments
1China

Registered in 5 markets

Where regulators' registries name Zhejiang Yahong Medical Apparatus Co., Ltd as the manufacturer or the registration holder of a device.

All markets
United States: 7 device types listedBrazil: 4 registrationsColombia: 1 registrationsIsrael: 1 registrationsSouth Korea: 1 registrations
RegisteredHome: ChinaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerZhejiang Yahong Medical Apparatus Co., Ltd7 device types—Below
BrazilANVISAManufacturerZHEJIANG YAHONG MEDICAL APPARATUS CO., LTD.42026–2026Pure Global AI
ColombiaINVIMAManufacturerZHEJIANG YAHONG MEDICAL APPARATUS CO, LTD1—Pure Global AI
IsraelAMARManufacturerZhejiang Yahong Medical Apparatus Co Ltd1—Pure Global AI
South KoreaMFDSManufacturerZHEJIANG YAHONG MEDICAL APPARATUS CO., LTD12020–2020Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Zhejiang Yahong Medical Apparatus Co., Ltd currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Orthodontic Screw Expansion RetainerDYJ · Class 1Retainers, expanders & headgearMaker
Yahong
2013
Orthodontic TubeDZD · Class 1Orthodontic wires & bandsMaker
Yahong
2013
Orthodontic Elastic BandECI · Class 1Orthodontic wires & bandsMaker
Yahong
2013
Orthodontic Preformed BandECM · Class 1Orthodontic wires & bandsMaker
Yahong
2021
Orthodontic Wire ClampECN · Class 1—Maker
Yahong
2013
Orthodontic Metal BracketEJF · Class 1Orthodontic bracketsMaker
Yahong
2013
Endodontic Pulp Canal FileEKS · Class 1Endodontic filesMaker
W3
2019

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Registered establishments

EstablishmentLocationWhat it does
Zhejiang Yahong Medical Apparatus Co., Ltd.FDA reg. 3010517827Huzhou Zhejiang, ChinaForeign exporter, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10045144). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.